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Completed

NCT Number: NCT00453362

A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib

This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-[18F]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-[18F]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory non-small cell lung cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in Australia and 2 sites in the United States.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent Form(s)
  • Histologically confirmed NSCLC
  • Recurrent or progressive disease after receiving at least one chemotherapy regimen for advanced or metastatic NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Age ≥ 18 years
  • Recovery from reversible acute effects of prior anti-cancer therapy (chemotherapy, radiotherapy, or investigational treatment) to NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 (excluding alopecia)
  • Ability to comply with the study and follow-up procedures, including all specified imaging studies
  • Ability to take oral medication
  • Availability of archival diagnostic paraffin-embedded tumor tissue and willingness to provide sufficient tissue for testing for EGFR levels in tumor by both immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH)
  • Life expectancy ≥ 3 months
  • Measurable disease on computed tomography (CT)
  • At least one detectable lesion on FDG-PET scan and/or FLT-PET scan that is measurable on CT
  • Use of an acceptable means of contraception (men and women of childbearing potential) or documentation of infertility

Exclusion criteria

  • Prior treatment with an investigational or marketed agent for the purpose of inhibiting epidermal growth factor receptor (EGFR) (including, but not limited to, erlotinib and gefitinib)
  • Chemotherapy, radiotherapy, or investigational treatment within 14 days or within 5 half-lives of the active molecules in the chemotherapy or investigational treatment, whichever is longer, prior to study entry or from which patients have not yet recovered
  • Inability to take oral medications, disease affecting gastrointestinal absorption, or prior surgical procedure affecting gastrointestinal absorption
  • Uncontrolled diabetes
  • Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within 1 month prior to study entry, hepatic, renal, or metabolic disease)
  • Pregnancy or lactation
  • History of another malignancy in the past 2 years, unless the malignancy has been adequately treated, is currently not detectable, and is associated with a 5-year survival > 90%
  • Claustrophobia
  • Any other disease, condition, physical examination finding, or clinical laboratory finding which, in the opinion of the investigator, makes the patient inappropriate for the study

Treatment and study plan

2-deoxy-2-[18F]fluoro-D-glucose (FDG)

Other

FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).

3'-deoxy-3'-[18F]fluorothymidine (FLT)

Other

FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.

Erlotinib HCl

Drug

Tablets taken orally 150 mg/day.

Other names: Tarceva

Primary outcomes

  1. Progression Free Survival (PFS) of Groups by FDG Response at Day 56

    Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years

    PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.

    PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.

    Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%.

  2. PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56

    Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years

    PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.

    PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <-25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.

  3. Progression Free Survival of Groups by FLT Response at Day 56

    Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years

    PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.

    PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.

    FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%.

  4. Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56

    Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years

    PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.

    PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib.

    FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.

  5. Overall Survival of Groups by FDG Response at Day 56

    Time frame: From first erlotinib treatment to death, assessed up to 2 years

    Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.

    Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%.

  6. Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56

    Time frame: From first erlotinib treatment to death, assessed up to 2 years

    Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.

    OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.

    FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.

  7. Overall Survival of Groups by FLT Response at Day 56

    Time frame: From first erlotinib treatment to death, assessed up to 2 years

    Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.

    OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.

    FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%.

  8. Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56

    Time frame: From first erlotinib treatment to death, assessed up to 2 years

    Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.

    OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.

    FLT-PET response was defined as a mSUVmax from FLT-PET scans of <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.

Secondary outcomes

  1. Percentage of Patients With FDG-PET Responses

    Time frame: Day 14 and Day 56

    In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment.

    FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%.

    CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.

  2. Percentage of Patients With FLT-PET Responses

    Time frame: Day 14 and Day 56

    In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment.

    FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.

  3. FDG Response in Subgroups by CT Response at Day 56

    Time frame: Day 56

    In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans <-25%.

    CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.

    CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.

  4. FLT Response in Subgroups by CT Response at Day 56

    Time frame: Day 56

    In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans <-25%.

    CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.

    CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.

  5. Number of Participants With Adverse Events Due to FLT-PET Imaging

    Time frame: From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.

    The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • Roche Pharma AG

Registry information

Official study title

Pilot Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 28, 2007
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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